Job Description
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Role Description
- We are looking for a (senior/principal) biostatistician to join the team of biostatistics as part of Quantitative Sciences. The position will be located in Ghent (Belgium) or Boston (US). Working remotely is possible.
- Serve as the indication expert biostatistician and lead all statistical activities of a major indication (across assets)
- Drive novel approaches and optimize the process across all stages of clinical development in the indication you are responsible for
- Drive quantitative data strategy of the indication and closely collaborate with stakeholders to lead delivery of all statistical deliverables
- Oversee delivery of all statistical deliverables for the indication and contribute to HA submissions
- Report to a franchise team leader within the Biostatistics and Modeling organization
- Carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirements
- Guide the team of statisticians supporting the different assets
- Qualifications
- Master or doctorate (Ph.D.) degree in Statistics or related field
- At least 7 years of experience in the biotech/pharma industry
- Proven record of leading statistical activities, including dossier submission and major agency interactions involving BLA/NDA/MAA (pre and post dossier submission)
- Expertise in drug development and experience driving complex innovative designs or cutting-edge methods
- Advanced knowledge of biostatistics and strong command of its application to clinical trials
- Proficient in statistical software (SAS and/or R)
- Able to collaborate with program partners and stakeholders to deliver on the statistical deliverables
- Ability to clearly explain complex statistical concepts in written and spoken English
- Team player with a focused attitude
- Able to work autonomously as part of a cross-disciplinary team in a dynamic environment
- Capable of motivating and empowering statisticians supporting you
- Benefits
- Member of a cross-disciplinary team involved in clinical development of therapeutic antibodies
- A work environment in a human-sized, dynamic, rapidly growing biotech company
- Competitive salary with extensive benefits
- Opportunity to grow and be part of a team driven by creativity, innovation, and science
- Eligibility to participate in short-term and long-term incentive programs
- Comprehensive benefits package, including retirement savings plans and health benefits
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